We will help you:
- Assess the prospects and the possibility of registering a medical device abroad
- Correctly determine the class of a medical device for registration according to the regulations of your selected countries
- Choose the optimal scheme for obtaining marking
- Choose ways to confirm compliance with international requirements for medical devices
- Develop technical documentation in accordance with the standards of the selected country or countries
- Organize technical testing, toxicological and clinical studies in accredited laboratories
- Collect and submit the registration dossier to the notifying authority
Confirmation of compliance
To register medical devices and preparations, including masks and gloves, it is necessary to confirm that they comply with the regulations of the country of import. For example, for import and sale in Europe, a medical device needs to obtain the CE-marking and confirm that your quality management system complies with the EU standard. Usually - through the international certificate ISO 13485.
Why is it easier to register a medical device abroad with IPS?
- Our experienced experts are familiar with the requirements of the EU and other countries and are constantly monitoring the changes in standards.
- We have established contacts with international experts, laboratories and attorneys in different countries.
- We accompany clients at all stages of registration and take on the difficulties associated with obtaining markings, certificates and registration certificates in the desired country.
- Contacting IPS saves you time and resources. We are engaged in registration from and to, and you are simply preparing for the successful import of medical products to markets of interest to you.
Contact us for details and to start the process of registering your medical device abroad.